Dentsply Sirona Gutta-Smart Manual

Gutta‑Smart™
Directions for Use
EN

Table of Contents
2
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
5 Step by Step Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . .9
5.1 Document Symbols and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.2 Package Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.3 System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3.1 Charging the Handpieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.3.2 Attaching Handpiece Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.3.2.1 Attaching Electric Heat Plugger (EHP) to Pack Handpiece . . . . . . . . . . . . . . . .13
5.3.2.2 Attaching Thermal Response Tip (TRT) to Pack Handpiece . . . . . . . . . . . . . . . 13
5.3.2.3 Attaching Heater (and GP cartridge) to Flow Handpiece. . . . . . . . . . . . . . . . .14
5.3.3 Programming the Handpieces — General Description . . . . . . . . . . . . . . 14
5.3.3.1 Programming the Pack Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.3.3.1.1 Programming the Pack Handpiece for the Thermal Response Tip (TRT) . . . . . . . . . . 17
5.3.3.2 Programming the Flow Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.3.4 Pack and Flow Handpieces — Common Features . . . . . . . . . . . . . . . . . 19
5.3.4.1 Pack Handpiece Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.3.4.2 Flow Handpiece Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Table of Contents
3
5.3.5 Handpiece Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.3.5.1 Pack Handpiece – Electric Heat Plugger (EHP) Operation . . . . . . . . . . . . . . . . 22
5.3.5.2 Pack Handpiece – Thermal Response Tip (TRT) Operation . . . . . . . . . . . . . . . 22
5.3.5.3 Flow Handpiece – Gutta-Percha (GP) Operation . . . . . . . . . . . . . . . . . . . . . . 23
5.3.5.4 Replacing the Flow Gutta-Percha (GP) Cartridge. . . . . . . . . . . . . . . . . . . . . .23
6 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . 24
6.1 Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.2 Base Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.3 Handpieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.4 Electric Heat Pluggers (EHP), Thermal Response Tips (TRT) and Flow Heaters
(HTR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.5 Gutta-Percha Cartridges (GP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7 Supplies and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . .27
8 Technical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . .28
9 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
10 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
11 Disposal of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
12 Identication of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . 37

Introduction
4
FOR DENTAL USE ONLY
Introduction
Congratulations on your purchase of the Gutta‑Smart™ cordless obturation
system.
These Directions for Use are always kept up to date by Dentsply Sirona to bring
them in line with the latest developments. You will nd the current version on the
website shown on the back cover page of this manual.
In countries where the legal situation enables us to do so, we have decided not to
produce a printed version of the Directions for Use, for environmental reasons.
If no printed version is enclosed in your national language and you wish to have
a printed one, we will be happy to send you a copy (free of charge within seven
calendar days to any address in North America). To order, simply send your request
to the contact shown on the back cover page of this manual.
The Directions for Use are available in other languages on request. These Direc-
tions for Use have been compiled with the utmost care; nevertheless, it is not
always possible to completely rule out the risk of error, despite all eorts to do so.
We would appreciate your feedback in this area. If any errors are noted, please con-
tact Dentsply Sirona at the address shown on the back cover page of this manual.
Dentsply Sirona reserves the right to change the information and data contained
in the Directions for Use without prior notice.
1 Indications for use
The Gutta‑Smart™ is a cordless obturation system designed for warm vertical
obturation. The system contains handpieces that are used for down pack (Pack)
and backll (Flow) techniques to obturate the root canal system.
The Pack handpiece is intended to heat electric heat pluggers for warming and
softening gutta-percha master cones and searing o gutta-percha cones. This
handpiece is also intended to heat a thermal response tip that subjects a tooth to
heat in order to determine pulp vitality.
The Flow handpiece is intended for heating and extruding gutta-percha into the
root canal system. The single-use gutta-percha cartridges are designed to place
heated gutta-percha into a cleaned and shaped canal.
The Gutta‑Smart™ device can only be used with Dentsply Sirona gutta-percha
cartridges, ow heaters, electric heat pluggers and thermal response tips.
— Indications for use

Contraindications
5
2 Contraindications
Read the following contraindications before use.
• This device must not be used in cases where a patient has been tted with
an implanted heart pacemaker (or other electrical equipment) and has been
cautioned against the use of small electrical appliances (such as electric shavers,
hair dryers, etc.)
3 Warnings
Read the following warnings before use.
• This device is intended to be used for lling a root canal with gutta-percha and
provide a heated endodontic plugger for packing the root canal lling material
into place and may only be used by trained and qualied dentists.
• Do not use this device for any dental procedure other than root canal obtura-
tion.
• Do not use the device in the presence of free oxygen, ammable anesthetic gas
mixtures or ammable substances.
• The device can cause radio interference or disrupt the operation of equipment
in the vicinity. If this happens, the interference should be reduced by reorienting
or repositioning the device or by screening o the immediate environment. The
electromagnetic radiations emitted by the device are below the recommended
limits specied by the applicable relevant provisions (DIN EN 60601-1-2:2007).
During Treatment
• Gloves and a rubber dam are mandatory during treatment.
• If any irregularities with the device should occur during treatment, turn it o.
Contact Dentsply Sirona by phone or online at the contact information shown
on the back cover page of this manual, or contact your Dentsply Sirona autho-
rized service partner.
• Thermal hazard risk exists for patients.
• When replacing a gutta-percha cartridge during a procedure, the ow heater
sleeve and expended cartridge may be hot to the touch.
• Allow the ow heater to cool before attempting to remove.
• Do not remove a hot gutta-percha cartridge!
• Electric heat plugger tips become hot during use. Turn o unit and allow cool-
ing before exchanging tips.
— Warnings